Webinars

SQA periodically organizes webinars for its members on a variety of regulatory quality assurance topics. Webinars often are free for SQA members. Occasionally, a webinar is offered for both members and non-members.

Wednesday, 21 February 2018, 10:00 AM-11:00 AM EST

Certificate of Analysis Essentials for Regulated Bioanalysis

Presented by: Marie-Christine Lacasse

Description:The exact composition and preparation of reference standard stock solutions directly impact analytical or bioanalytical calculated sample concentrations. The webinar will examine certificates of analysis for reference standards used in regulated analysis. A focus will be put on what should be included in a certificate of analysis and how to interpret the various analytical results described therein. Potency and certificates for peptides standards will also be discussed.

This presentation will NOT be recorded. Please join the live webinar to see the presentation.

Wednesday, 14 March 2018, 11:00 AM-12:00 PM EST

The Psychology of Metrics

Presented by: Leslie Sidor

Description:Oversight of clinical studies and the activities required to support clinical trials is a necessary activity to maintain data and scientific integrity and to protect the safety and welfare of subjects. Whether the work is conducted by a contract research organization or the sponsor, a consistent oversight model is required that is integrated into the sponsor’s Quality Management System (QMS). At Biogen, the R&D oversight model determines ownership for defining key quality indicators (KQI’s), the measurement of process health and assessment of output quality. In this model, metric owners are the individuals who are accountable for the quality and compliance of a specific process output (e.g. Trial Master File, statistical analysis plan, etc.). The process owner needs to
• Select KQI’s aligned to the fundamental R&D principles which define quality expectations by the senior leadership team
• Set meaningful tolerance thresholds based acceptable risk which trigger corrections and/or CAPAs based on the quality impact
In addition to specific process oversight, overall process performance health is collected and reported in a dashboard. The dashboard is used as a governance tool to inform leaders of potential quality and compliance risks in R&D.
In this presentation, Biogen’s oversight model and QMS will be reviewed in the context of identifying KQI’s, setting tolerance thresholds, acceptance of risk, escalation of issues and governance. A case study will be presented to bring these concepts to life and share the tools, practical points to consider and learnings identified along the way.

Registration coming soon

RQAP Re-registration units: 0.25 GCP/non-GLP

To Present an SQA Webinar

SQA Committees, Specialty Sections, Regional Chapters and members ONLY:
To request to present a topic in a webinar, please complete a Webinar Request Form. (You will be asked to sign in.)

Webinar Library

SQA has developed a library of past webinars for which we had authorization to record the presentation or share slides.

SQA members may "purchase" access to webinar recordings and PDF slides for $0.00. Non-members may purchase access for a small fee. In either case, the purchasing process adds the webinar to your "My SQA Online Education button" on your My SQA page. (You must log in to access this page.)

Webinar descriptions and links for purchasing are in the webinar library: